(Not Applicable)
The present invention relates generally to stopcocks, and more particularly to a stopcock having an axially rotatable core.
A stopcock is a cock or valve for stopping or regulating the flow of a fluid (including liquids and/or gasses). In medicine, a stopcock is most typically used for regulating the flow of intravenous (xe2x80x9cIVxe2x80x9d) fluids or medications into, or out of, a patient as part of an intravenous system. In this regard, stopcocks provide a quick and sterile way for diverting intravenous fluid flow or medication into a patient by changing the flow path in the IV line system.
A stopcock can also be used to divert fluids or air into devices, such as for filling skin expanders with fluid or air during skin grafting, for filling breast implants with saline during breast augmentation procedures, for diverting spinal fluid into a manometer to measure spinal fluid pressure during a spinal tap, and for diluting viscous packed red blood cells with saline to make them less viscous for subsequent rapid infusion into the patient during transfusions.
Stopcocks are frequently used as a needle-less intravenous injection port. That is, once the initial IV injection port has been opened using a first needle, subsequent injections and infusions are possible through the same injection port via a stopcock having three ports separated by a shut off valve. Stopcocks provide an inexpensive method of avoiding needle-stick injuries and for a clinician to comply with the FDA mandate xe2x80x9cto use needle-less injection techniques whenever possiblexe2x80x9d. Typically, stopcocks are formed of injection molded plastic. As such, stopcocks are inexpensive and disposable after use on a single patient.
Early stopcock designs were simply used as xe2x80x9con and offxe2x80x9d valves to start or stop intravenous infusions. Such designs contained two ports, an inlet port and an opposing outlet port. A lever extending from between the two ports was used as a shut off lever. Fluid was configured to only flow between the two ports. These first stopcocks designs were designated as two-port, one-way stopcocks.
Another prior art stopcock design includes a stopcock body with three ports which are arranged in a T-shaped configuration, and a stopcock core having a lever extending radially from an axial portion. The ports can be selected at the option of the user by rotating the lever to a position determined by the direction of desired flow. A xe2x80x9cstopxe2x80x9d tab is disposed on the stopcock body which prevents the lever of the stopcock from being turned to a position where all three ports are open and flow into one another at one time, i.e., such that the T-shaped path of the body and the T-shaped path of the core are fully aligned. Because fluid can flow three different ways, these stopcocks are designated as three-port, three-way stopcocks.
Referring now to FIG. 1A, there is depicted a prior art stopcock 2 which is a three-port, four-way stopcock. It does not have a stop tab as in the threeport, three-way stopcock to prevent the lever from being turned to a position opposite the right angled port. The stopcock 2 includes a body 4 having an entry port 6, an exit port 8 and an injection port 10, and a core 12. The core 12 includes a rotating axial portion 14 connected to a lever 16.
Referring to FIG. 1B and FIG. 1C, the axial portion 14 of the core 12 has a first flow channel 18, a second flow channel 20 and a third flow channel 22 which form a confluent xe2x80x9cTxe2x80x9d configuration. The lever 16 generally includes the word xe2x80x9coffxe2x80x9d 24 and an arrow 26 molded on its upper surface to show which direction fluid will not flow. The arrow 26 and the word xe2x80x9coffxe2x80x9d 24 do not directly indicate to the user which way the medication or fluid will flow.
The stopcock 2 is a four-way stopcock because fluid can flow in four different ways. First, when the lever 16 points toward the entry port 6, fluid can flow between the injection port 10 and exit port 8. Second, when the lever 16 points toward the injection port 10, fluid can flow between the entry port 6 and exit port 8. Third, when the lever 16 points toward the exit port 8, fluid can flow between the entry port 6 and injection port 10. Finally, when the lever 16 points opposite the injection port 10, i.e., toward no port, fluid can flow between all three ports 6, 8, 10 at one time.
Referring to FIG. 2, there is depicted the body 4 of stopcock 2. The entry port 6, exit port 8 and injection port 10 are located in a single horizontal plane and are confluent at a central chamber 28, which is filled with the axial portion 14 of the core 12 when the stopcock 2 is assembled. The entry port 6 has a female luer lock connector 30 and is the main fluid entry end of the stopcock 2. It usually is connected to a male luer-lock connector 32 from an IV set connected to a bag of an IV fluid. The exit port 8 has a male luer lock or luer slip connector 32 and is the fluid exit end of the stopcock 2 and is usually connected to a female luer lock connector 30 of an IV extension set which ultimately connects to an IV catheter in a patient. The injection port 10 protruding perpendicularly from the middle of the straight line flow path formed by the entry port 6 and exit port 8 has a female luer lock connector 30 and is used for adding medication or fluids to the IV system.
Referring to FIG. 3, there is depicted a core 12 having the axial portion 14 and the lever 16. The lever 16 rotates in a horizontal plane which is parallel to the horizontal plane formed by the three fluid flow ports 6, 8 and 10. The procedure a clinician must follow to perform a typical IV injection or infusion using a conventional three-port, four-way stopcock 2 is fraught with difficulty and risk. An examination of this procedure makes clear the need for an improvement, such as that of the present invention described further below.
A typical intravenous setup using a three-port, four-way stopcock 2 has the exit port 8 typically connected to an IV extension tubing which is subsequently connected to an IV catheter in the patients vein. The entry port 6 is connected to a main IV administration set which is in turn connected to a bag of IV fluid, and the injection port 10 normally has a syringe or a secondary IV fluid line connected to it. When a syringe is attached to the injection port 10, the bulk and length of the syringe requires that the syringe-stopcock assembly sits on a surface wherein a single plane is formed by the flow ports 6, 8, 10 of the stopcock 2 and the attached syringe. The axial portion 14 then extends vertically upward from, and the lever 16 rotates in a plane parallel to, that surface. To turn the lever 16 in a desired direction, a first hand of a clinician is held palm up in a horizontal plane, with the fingers pointing upward in a vertical direction, to stabilize the syringe-stopcock assembly, and a second hand of the clinician is held above the lever 16, with fingers pointing in a downward, vertical direction, for grasping and rotating the lever 16.
This prior art stopcock arrangement is awkward for the clinician. With the first hand below and the second hand above the stopcock 2, the clinician must first determine which way to turn the lever 16 to obtain the desired fluid flow, and then he or she must turn it in the correct direction, either clockwise or counter-clockwise, with fingers of the second hand. When the clinician is assured that the stopcock 2 is secure in the grasp of the first hand only, the second hand releases the lever 16 and grasps the barrel of the syringe attached to the injection port 10. The second hand then pushes or pulls the plunger of the syringe to give an injection of medication or to aspirate fluid. The second hand must next move from the syringe barrel back to its previous position grasping the lever 16 of the stopcock 2 and rotating it back to its original position. This procedure is cumbersome and time consuming, and involves twice moving one hand between two perpendicular planes.
It is therefore evident that there exists a need in the art for an improved stopcock in comparison to the prior art designs.
In accordance with an aspect of the present invention, there is provided a stopcock for use with a syringe. The stopcock includes a stopcock body. The stopcock body includes a central axial opening formed in the stopcock body. The stopcock body further includes a first stopcock luer connector extending radially from the stopcock body and in fluid communication with the central axial opening. The stopcock body further includes a second stopcock luer connector extending radially from the stopcock body and in fluid communication with the central axial opening. The stopcock further includes a stopcock core axially disposed within the central axial opening. The stopcock core includes an engagement end axially connectable with the syringe. The stopcock core further includes an axial port formed at the engagement end for fluidly communicating with the syringe. The stopcock core further includes a first radial port formed in the stopcock core. The stopcock core further includes a first passage formed in the stopcock core extending between the axial port and the first radial port. The stopcock core has a first position with the first radial port in fluid communication with the first stopcock luer connector. The stopcock core has a second position with the first radial port in fluid communication with the second stopcock luer connector. The stopcock core is rotatable from the first position to the second position upon the syringe being axially connected to the engagement end and axially rotated.
Advantageously, the stopcock core may be rotated about a longitudinal axis as initiated by rotation of an attached syringe. Thus, rotation of the syringe is contemplated to selectively direct the direction of the first radial port in relation to the stopcock body, such as between the first and second positions.
According to an embodiment of the present invention, the stopcock core has a second radial port and a third radial port formed in the stopcock core, and a second passage formed in the stopcock core extending between the second radial port and the third radial port. The third radial port is disposed opposite the second radial port. The first radial port is disposed perpendicular to the second and third radial ports. The second radial port is in fluid communication with the second stopcock luer connector with the stopcock core in the first position. In addition, the stopcock body may have a third stopcock luer connector extending radially from the stopcock body and in fluid communication with the central axial opening. The third radial port is in fluid communication with the third stopcock luer connector with the stopcock core in the first position. Further, the engagement end may be a female connector, and the syringe may have a male connector for engaging the engagement end in fluid communication. The engagement end may be threadedly connectable with the syringe. The first stopcock luer connector may be a male connector, and the second stopcock luer connector may be a female connector.
Accordingly, the present invention represents a significant advance in the art.